Cleared Traditional

K990138 - DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

K990138 is an FDA 510(k) clearance for DSL ACTIVE AFP ELISA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Immunology device with product code LOJ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K990138 · Diagnostic Systems Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
153d
Days
Class 2
Risk

K990138 is an FDA 510(k) clearance for the DSL ACTIVE AFP ELISA, MODEL DSL-10-8400. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K990138

510(k) Number K990138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date June 21, 1999
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOJ Device Classification - Class 2, Special Controls

Product Code LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 14
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K990138.
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · Tosoh Medics, Inc. · Dec 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · Bayer Diagnostics Corp. · Oct 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · Bayer Corp. · Mar 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · Ortho-Clinical Diagnostics, Inc. · Dec 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · Diagnostic Products Corp. · Dec 1998
ELECSYS AFP
K981282 · Roche Diagnostics GmbH · May 1998